Shares of INmune Bio (NASDAQ:INMB) more than doubled on July 14th following the company’s announcement of positive Phase 1b data on XPro1595 for patients with Alzheimer’s Disease. The interim trial showed that the drug candidate decreased neuroinflammation by 40.6% in a part of the brain that is considered important for learning and memory.
INmune is a LaJolla, California-based immunology company that develops treatments to harness a patient’s innate immune system to fight disease. Its development pipeline includes treatments for Alzheimer’s disease, COVID-19 complications, and NASH.
The early stage clinical trial of XPro1595 for Alzheimer’s patients demonstrated that the treatment reduces white matter free water, a biomarker of neuroinflammation in the brain that is measured by magnetic resonance imaging (MRI).
XPro1595 is INmune’s next-generation tumor necrosis factor (TNF) inhibitor that neutralizes an inflammatory protein associated with Alzheimer’s Disease pathology.
Significant decreases in brain inflammation observed
The company compared biomarker data from six Alzheimer’s patients that were treated with XPro1595 for a period of 12 weeks to data from 25 Alzheimer’s patients that are in a history database associated with the Alzheimer’s Disease Neuroimaging Initiative (ADNI). ADNI is a national study across multiple locations that aims to improve clinical trials targeting Alzheimer’s disease.
The six patients treated weekly with 0.3mg/kg of XPro1595 had a whole brain inflammation increase of 1.7% while those that were treated weekly with a 1.0mg/kg dose had a 2.3% inflammation decrease. This data contrasted with a 5.1% inflammation increase in the ADNI patients.
A more detailed analysis of the XPro1595 patients showed that neuroinflammation decreased 40.6% in the Arcuate Fasciculus, an area of the brain that connects the caudal temporal cortex and the inferior front lobe and that is commonly associated with language and short-term memory. Arcuate Fasciculus neuroinflammation increased 4.6% in the study’s ADNI cohort.
The trial took place at several clinical sites located in Australia including at The Australian Alzheimer’s Research Foundation.
INmune Director of Neuroscience Dr. C.J. Barnum commented, “We are extremely encouraged by these findings at such an early stage in our clinical trial. Not only do we see a clear reduction in neuroinflammation, but we also know where in the brain this is occurring, which may inform us on the domains of cognition that might be affected.”
INmune’s share price was significantly affected by the announcement as it soared from a $8.85 close on July 13th to over $18.00 the next day.
The company hosted a key opinion leader (KOL) event before the market open on July 14th which included a presentation of the data followed by a panel discussion that included several experts in the neuroscience field.
INmune plans to use the Phase 1b study to identify the dose of XPro1595 that will be used in a larger Phase 2 disease modification study.
The market will also be looking forward to the company’s second quarter financial results which are scheduled for August 10th.